EU MDR Annex I compliance — simplified.
EU MDR 2017/745 requires documented evidence of biocompatibility for materials in contact with the body. VendorWeave provides a pre-built MDR materials declaration form that you send to suppliers, track responses in real time, and store with full audit trails for Notified Body inspections.
- Pre-built MDR materials declaration form compliant with Annex I requirements
- Track submission status per supplier — sent, received, pending, overdue
- Responses stored with full audit trail for regulatory inspections
How it works
MDR Materials Declarations in three steps.
Send declaration request
VendorWeave emails the MDR materials form to the supplier with a secure portal link.
Supplier completes form
The supplier fills in material composition, biocompatibility data, and substance declarations.
Response logged
Completed declarations are stored with timestamps and linked to the supplier profile for audit readiness.
Why MDR Materials Declarations?
Pre-built MDR materials declaration form compliant with Annex I requirements
Track submission status per supplier — sent, received, pending, overdue
Responses stored with full audit trail for regulatory inspections
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Explore other features included with Compliance Tracking.
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